Depression and nutrition problems after surgical site infections in orthopedic patients
Incidence of Depression and Its Complications After Surgical Site Infection - ISODEP.
NA · University Hospital, Bordeaux · NCT07125196
This study will see how often adults treated for surgical site infections after orthopedic surgery develop depression or problems like malnutrition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT07125196 on ClinicalTrials.gov |
What this trial studies
This is a prospective, monocentric observational cohort conducted in the Orthopedic Surgery Department at the University Hospital of Bordeaux enrolling adults treated for surgical site infections after prosthetic, spinal, or trauma-related orthopedic procedures. Over a five-year enrollment period, investigators will collect demographic, clinical septic, psychiatric, and nutritional data using medical records and self-administered questionnaires. Patients will be followed for up to three years to document new-onset depression and related complications such as malnutrition and the care provided. The goal is to describe incidence, timing, and risk factors to inform prevention and patient management pathways.
Who should consider this trial
Good fit: Adults (over 18) treated for surgical site infections after orthopedic limb or spine surgery — including prosthetic, spinal, or trauma osteosynthesis cases — who can give informed consent and meet the study's inclusion/exclusion criteria.
Not a fit: Patients with a prior diagnosis of depression, BMI < 18.5, active cancer or chronic inflammatory disease, those under legal protection or unable to consent, pregnant or breastfeeding women, and people treated outside the enrolling center are unlikely to benefit or be eligible, and single-center results may not generalize widely.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify patients at higher risk of depression or malnutrition after surgical site infection so they can offer earlier support and tailored care.
How similar studies have performed: Previous work has suggested links between postoperative infection and worsened mood or nutritional status, but prospective long-term studies focusing specifically on SSI-driven new-onset depression and malnutrition are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient \>18 years old * Patient treated in infectiology for surgical site infection after orthopedic surgery of the limbs or spine: * Prosthetic limb surgery * Spinal surgery * Traumatology: Osteosynthesis of peripheral limbs or spine Exclusion Criteria: * Patient under guardianship or curatorship, * Pregnant, breastfeeding woman * Person deprived of liberty by judicial or administrative decision, * Person undergoing psychiatric treatment under duress requiring the consent of the legal representative. * Person unable to express their consent, * Person under legal protection, * Patient not affiliated to a social protection scheme. * Patient with a history of diagnosed depression, hospitalization for depressive disorders or taking mood-regulating treatments. * An initial BMI of less than \< 18.5, the existence a cancerous pathology, an ongoing inflammatory disease, a pathology responsible for chronic undernutrition
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (RECRUITING)
Study contacts
- Principal investigator: Benjamin BOUYER, PROF — University Hospital, Bordeaux
- Study coordinator: Benjamin BOUYER, PROF
- Email: b.bouyer@chu-bordeaux.fr
- Phone: +335 56 79 87 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgical Site Infections, Depression, Malnutrition, surgical site infection, depression, malnutrition, orthopedic surgery, mood disorders